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Speaker
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Presentation
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Alberto Gutierrez & staff
FDA/CDRH/OIVD
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OIVD Roundtable Discussion
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Carol Benson
FDA/CDRH/OIVD/DCTD
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How to Prepare and File for CLIA
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Jonathan Kahan, JD
Hogan & Hartson
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IVD Industry Overview
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James Kelly
Roche Molecular Systems
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PMA Applications: Perspectives from an IVD Manufacturer
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Bradley Thompson, JD
Epstein, Becker & Green
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The Past, Present and Future of Good Reprint Practices
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Janice Hogan
Hogan & Hartson
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FDA Regulatory Considerations in Transfer of Ownership of Diagnostic Technology
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Connie O'Connor and Gary Bennett, PhD
KEMA Quality BV
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IVD General classification as Proposed by the GHTF SG1
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Rick Naples
Becton Dickinson
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Legislative & Policy Landscape Under New Congress & New Administration
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Eric Lawson
Voisin Consulting, Inc.
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Companion Diagnostics in Personalized Medicine Worldwide
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Nathan Conover
PathWise Inc.
(presented by Karen Richards of Celera)
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Integrating Risk Management into Quality System
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Sharon Kapsch
RSMB
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Medical Device Reporting: eMDR
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Gary Anderson, DVM, PhD
Kansas State University Veterinary Diagnostic Laboratory
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Veterinary Diagnostics: Concept to Market
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Sam Rua
Beckman Coulter
(presented by Rick Naples of BD)
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Risk Based Regulation of Emerging Diagnostics: An Update on AdvaMed's Tier Triage Proposal
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Elizabeth Mansfield, PhD
FDA/CDRH/OIVD
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Current Policy Topics in OIVD
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